Tag: 21 CFR Part 820

21 CFR PART 820 QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls 820.70 Production and process controls (a) General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control

Login Status

Contact Info

Categories

Categories

About Us

Our services include, but are not limited to, the following on a global basis including US FDA, EU (European Commission), Health Canada, Korea MFDS, CFDA, and Therapeutic Goods Administration (TGA), etc.